Boehringer Ingelheim has submitted European marketing authorization applications (MAA) to extend the indication to use tiotropium (Spiriva) Respimat for the treatment of asthma in adults aged 18 years and over.
The MAA is based on results from the UniTinA-asthma Phase III clinical trial program which involves over 4,000 patients in over 150 sites globally.
The program is aimed at assessing the efficacy and safety of tiotropium Respimat in patients with asthma.
Boehringer Ingelheim corporate senior vice president Medicine Klaus Dugi said the company's extensive studies have showed that tiotropium Respimat has the potential to be an effective new treatment option which can provide benefits as well as improve outcomes for adult patients with asthma.
"Furthermore, we look forward to results from the paediatric UniTinA-asthma Phase III studies which are anticipated to become available in 2014," Dugi added.
"At least 40% of patients with asthma remain symptomatic and may experience frightening and life-threatening asthma exacerbations (attacks), despite using the available therapeutic options, and we believe that tiotropium, once approved, can help address this clear unmet medical need."
A total of 11 Phase III studies investigating tiotropium Respimat added to standard treatment in adults, adolescents and children (age 1+) with persistent asthma across the spectrum of asthma severity, are included in the clinical trial programme.
The first data to come from the programme were the PrimoTinA-asthma studies, which showed the efficacy and safety of tiotropium in asthma patients who remained symptomatic despite treatment with at least ICS/LABA therapy.
Data from the PrimoTinA-asthma studies showed that the addition of tiotropium Respimat increased time to first severe asthma exacerbation and also time to first episode of asthma worsening compared with placebo.
The data secured from the MezzoTinA-asthma Phase III twin studies were also included in the MA applications for tiotropium Respimat in asthma.
The twin studies showed that, in asthma patients who remain symptomatic despite moderate-dose maintenance ICS therapy, the addition of tiotropium Respimat improves lung function, offers sustained bronchodilation over 24 hours and provides a statistically significant and clinically relevant improvement in asthma control.